Should You Trust Health Apps on Your Phone?

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Personal health is becoming increasingly mobile, and there are
now thousands of apps aiming to address everything from lifestyle
issues to chronic diseases. But can you trust these apps, the
same way you trust your prescribed drugs and medical
devices?

Medical devices are generally regulated by the U.S. Food and Drug
Administration, and although the FDA reviews some apps,
experts say the agency's power and efforts aren't nearly enough
to cover the 97,000 and counting health apps out there that are
transforming consumer health.

"The FDA is woefully understaffed and under-resourced to oversee
these things, particularly given the number of the thousands of
apps that are [most likely] under FDA's jurisdiction," said
health law expert Nathan Cortez, an associate professor of law at
Southern Methodist University Dedman School of Law in Dallas,
Texas. [ 9 Odd
Ways Your Tech Devices May Injure You ]

In an editorial published in The New
England Journal of Medicine on Thursday (July 24), Cortez and
his colleagues argued that health and medical apps hold the
promise of improving health, reducing medical errors, avoiding
costly interventions, and broadening access to care. But to reach
their potential, these products have to be safe and effective,
they said.

A large number of health apps, such as those that help you track
your exercise or the calories in your meals, likely don't pose a
concerning risk to consumers. But in more ambitious apps, such as
an app to manage insulin doses for diabetic patients, any
mistake, bug or misinformation could simultaneously affect
thousands of patients, and emerging
evidence reveals many products do not work as claimed, or the
products make mistakes.

"Early studies evaluating whether these apps work or not tend to
paint a pretty dim picture of them. The results aren't that
promising," Cortez told Live Science.

In September 2013, the
FDA gave its position on what types of products and
technologies would fall under its jurisdiction. Currently, the
agency has a pre-market review process for some apps, meaning
that the app developer submits information to the agency to get
the FDA's blessing, Cortez said. The agency also sometimes takes
enforcement actions by issuing a public reprimand to a company if
its products violate FDA's rules and regulations.

So far, the FDA has cleared about 100 medical apps over the past
decade, with about 40 of these approvals coming in the past two
years, according to the agency. These apps are mobile forms of
traditional medical devices, or are accessories to a regulated
medical device. For example, one app evaluated lets physicians
see data
from electrocardiograms, and another offers medication
reminders and connects patients with their doctors.

Still, the FDA's jurisdiction is limited, and the line between
what constitutes a medical app and what is just about health and
fitness could be blurry, which is frustrating for developers,
Cortez said.

Although a number of laws have been proposed in Congress that aim
to change the FDA's regulatory approaches, none have passed so
far. One of the main arguments against expanding the FDA's
oversight is that too much regulation would stifle innovation in
the mobile health industry.

But Cortez said that this common refrain is shortsighted. "If you
let these apps proliferate without any real oversight or any real
enforcement, I think you risk consumer confidence in these
products becoming really low," he said. "If the majority of apps
don't work, and make claims that aren't substantiated, I think
that will undermine the market in the long run."

Clear and decisive rules by the FDA could help mobile health
technologies mature into the next generation that actually
fulfill all the promises that the industry has for these
products, Cortez said.

"It looks like Congress is building momentum towards some kind of
legislation, some type of bill actually passing," Cortez said. If
Congress does pass a bill, it should give the FDA more resources
and push the agency to provide clear, binding rules for these
products, he said. "I think that'll help the industry in the long
term."

Should you trust the medical apps on your phone?

Mobile health and medical technology apps are still in the early
stages, but for every few hundred that don't do anything, there
are several apps that are actually helpful.

People who would like a useful app for their health condition
should make sure that the app is reputable, has been updated and
doesn't have bugs. They should also keep an eye out for recalls
and look for FDA-cleared apps, Cortez said.

"For example, if I had diabetes,
and I was looking to use an app, I would definitely try to use
one that the FDA has cleared in pre-market review process over
one that hasn't been cleared," Cortez said.

However, Cortez noted that even though the products may have gone
through the FDA's clearance process, they haven't been tested as
rigorously as new drugs and medical devices.

"I would also make sure my doctor knew what I was doing," Cortez
said. "It would be a joint decision with the doctor."